製藥業是一種高度技術密集、高投資、高風險、高利潤的產業，需藉由不斷地研發出新藥，才能持續保有企業的高獲利及高競爭力。政府已將製藥工業列為十大新興產業之一，期盼能提升國內藥廠競爭力及研發水準。我國藥廠以學名藥廠為主，研發多係從事於新劑型的開發，至今尚未有一項國人自行研發成功上市的新成分藥品。新藥大都由國外大藥廠主導開發。
本論文擬藉由探討先進國家藥品查驗登記制度中相關之智慧財產權保護措施，作為我國在制定相關規定之參考，期能在保護原開發廠的智慧財產權之際，亦能同時兼顧國內製藥產業的發展。本論文主要探討之議題有三：(一)仿傚美國新藥專利登錄制度，作為核發學名藥許可證之準據的必要性；(二)未經公開之醫藥品上市申請資料的保護與實施資料專屬權之必要性；(三)我國學名藥廠在新藥專利期間主張試驗實施例外之適法性。
第一章是緒論，說明研究之動機、範圍及目的。第二章分析製藥產業的特性，並就新藥研發及藥品上市過程進行介紹。美國的新藥研發能力堪稱世界的翹楚，然同時亦存在廣大的學名藥市場，其如何藉由法規的訂定，規範新藥及學名藥的查驗登記，調和二者間的利益衝突是第三章所欲探討之內容。近年來，歐美國家所主張的醫藥品資料專屬權之性質、各國實施的現況及其在TRIPS 39.3協定中之定位為何，第四章試圖釐清。我國學名藥廠可否依現行專利法主張試驗實施例外，以便在原開發廠藥品專利期屆滿前即開始進行相關的上市試驗？由於我國未如美國專利法明定准許上述之行為，於此有賴參酌日本、歐洲之法制，以決定其適法性，第五章將就先進國家有關依藥品試驗實施例外之規定進行剖析。第六章將就我國現行查驗登記制度中，對於藥品智慧財產權的保護現況進行討論。第七章為相關議題之結論與建議。
本論文結論認為：(一)現階段尚無仿傚美國新藥專利登錄制度之必要性；(二) 應邀集原開發廠及學名藥廠代表，就資料專屬權內涵、適用範圍和期限及對國內實際影響進行討論，研議出適合我國國情之醫藥品資料專屬權保護政策；(三) 放寬專利法第五十七條第一項第一款試驗實施例外原則之適用要件及範圍，刪除「非營利」之要件或在專利法或藥事法中，明定學名藥廠為取得上市許可，而在新藥專利期屆滿前進行相關上市試驗之行為可以免責。

第一章 緒論 1
第一節 研究動機 1
第二節 研究範圍與目的 5
第二章 新藥之研發 6
第一節 製藥產業的特性 6
第二節 新藥研發及上市流程 8
第三章 藥品查驗登記制度-以美國為例 13
第一節 Hatch-Waxman Act實施前之藥品上市規定 13
第二節 Hatch-Waxman Act實施後之藥品上市規定 15
一、簡易新藥申請程序 15
二、學名藥競爭條款 17
(一) 三十個月停止審核期 17
(二) 180天獨占權 17
(三) 資料專屬權 18
三、與醫藥品查驗登記相關之專利法修正 19
(一) 醫藥品專利期間之延長 19
(二) 醫藥品專利侵權之規定 19
第三節 Hatch-Waxman Act實施後查驗登記制度之弊端及改善方案 21一、Hatch-Waxman Act之弊端 21
二、Hatch-Waxman Act弊端之改善方案 24
第四章 未經公開之醫藥品上市申請資料的保護與資料專屬權 27
第一節 醫藥品上市申請資料保護背景 29
一、醫藥品上市申請資料保護的爭議 29
二、TRIPS 39.3制定前國外實務狀況 31
第二節 TRIPS 39.3與醫藥品上市申請資料保護之關係 34
一、TRIPS 39.3規範下醫藥品上市申請資料受保護的要件 34
二、TRIPS 39.3規範下會員國應盡之義務 37
三、TRIPS 39.3的協商經過 43
四、Bayer Inc. v. Attorney General of Canada 46
五、小結 48
第五章 醫藥品專利期間之試驗實施例外 50
第一節 美國專利法上之試驗實施例外 50
一、普通法規範架構下之試驗實施例外原則的起源與發展 51
二、成文立法之試驗例外 54
三、小結 58
第二節 日本專利法上之試驗實施例外 59
一、日本新藥和學名藥的上市核准過程 60
二、日本試驗實施例外判決之衝突 61
三、日本最高法院允許學名藥廠進行上市許可之相關試驗 63
四、小結 64
第三節 歐盟主要國家專利法上之試驗實施例外 65
一、歐洲專利公約 65
二、共同體專利規則 65
三、歐盟主要國家專利法上之試驗實施例外之現況 67
(一) 德國 67
(二) 英國 71
(三) 荷蘭 72
(四) 法國 73
(五) 歐盟現況 74
四、小結 75
第四節 WTO架構下有關試驗實施例外之規範 75
一、TRIPS協定下專利權之例外規定 75
二、加拿大藥品專利保護案 76
三、小結 82
第六章 我國現行查驗登記之智慧財產權保護現況評析 83
第一節 仿傚美國新藥專利登錄制度之必要性 83
一、我國現行措施 83
二、我國建立新藥專利登錄之必要性 83
第二節 我國實施資料專屬權之必要性 85
一、我國現行對未經公開之醫藥品上市申請資料的保護措施 85
二、我國實施資料專屬權之必要性 85
第三節 學名藥廠在新藥專利期間主張試驗實施例外之適法性 89
一、我國現行專利法上試驗實施例外之規定 89
二、我國現行法適用之困難 91
第七章 結論與建議 93
參考文獻 98

一、中文部分：
學位論文
1.黃崇銘，原開發藥廠新藥上市程序與其智慧財產保護功能之初探，交通大學管理科學研究所碩士論文，1997年。
2.王世晞，製藥產業之演進、現況、與趨勢，台灣大學商學研究所碩士論文，2004年。
3.李逢春，生物科技發展下台灣製藥產業之經營現況與策略，元智大學管理研究所碩士論文，2003年。
4.邱凱迪，WTO與貿易有關之智慧財產權協定與公共健康之研究-以醫藥專利問題為中心，東吳大學法律研究所碩士論文，2003年。
中文書目
1.衛生署，藥品查驗登記審查準則，1999.7編印
2.行政院衛生署，藥品非臨床試驗安全性規範，1998.6編印
3.衛生署，藥品生體可用率及生體相等性試驗基準及相關資料，1998.5 編印
4.生物技術開發中心，醫藥產業年鑑2003， 2003.9編印
5.謝銘洋，智慧財產權之基礎理論，翰蘆圖書，2001.6三版
6.經濟部工業局，2003生技產業白皮書，2003.10編印
7.楊崇森，專利法理論與應用，三民書局，2003年
中文期刊及專論
1.朱世霓，美國學名藥上市長路漫漫，科技法律透析，2003.3
2.陳文吟，論專利法上醫藥品專利權期間之延長－以美國法為主，華岡法粹，第24期，1996.10
3.陳文吟，探討因應醫藥品專利之合理措施，國立中正大學法學集刊，第8期，2002.07
4.陳啟桐，專利法上研究免責條款之比較與分析-以生物科技與醫藥產業為例，2003全國科技法律研討會論文集，國立交通大學科技法律研究所主辦，2003.11
5.李幸懋、徐宏昇，日本最高法院「學名藥(Generic Drug)」判決評析，1999全國智慧財產權討論會論文集，國立交通大學，1999.11
6.李素華，區域性專利制度整合之國際趨勢─歐洲專利及共同體專利制度，智慧財產權管理季刊，第31期，2001.12
7.李素華，專利權行使之限制-從美國及歐洲法律實務看試驗例外對於產業發展之影響，2003全國科技法律研討會論文集，國立交通大學科技法律研究所主辦，2003.11
8.黃立，GATT/WTO爭端解決機制總論，月旦法學雜誌，第79期，2001.12
9.劉棠必，研究除外原則在專利法架構下之問題研究─以我國現階生物科技基礎研發之特質為例（上），智慧財產權月刊，第55期，2003.7
10.劉棠必，研究除外原則在專利法架構下之問題研究─以我國現階生物科技基礎研發之特質為例（下），智慧財產權月刊，第56期，2003.8
11.李鎂，解讀專利法第五十七條─兼論台灣嘉義地方法院九十年易字第八十二號判決，智慧財產權，第46期，2002.10
12.宋皇志，WTOTRIPS架構下專利侵權之新態樣：為販賣之要約，月旦法學雜誌，第99期，2003.8
二、外文部分
英文書目及專論
英文書目及專論
1.Javasharee Watal, (2001), Intellectual Property Rights in the WTO and Developing Countries, Kluwer Law International, The Hague/London/Boston.
2.Jacques J. Gorlin, (1999), An Analysis of the Pharmaceutical-Related Provisions of the TRIPS (Intellectual Property) Agreement
3.Trevor Cook, (2000), Special Report: The protection of regulatory data in the pharmaceutical and other sectors, Sweet & Maxwell, London
4.Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, (July 2002), available at: http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf
5.Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmaceutical Industry Profile 2003 , available at: http://www.phrma.org/publications/publications/profile02/index.cfm
6.U.S. Food and Drug Administration, the Evolution of U.S. Drug Law, available at: http://www.fda.gov/fdac/special/newdrug/benlaw.html
7.FDA, Guidance for Industry, Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Mar 2000), available at: http://www.fda.gov/cder/guidance/3659fnl.pdf
8.Recent Developments Which May Impact Consumer Access to, and Demand for, Pharmaceuticals: Hearing Before the Subcomm. On Health of the House Comm. On Energy and Commerce, 107th Cong. (June 13, 2001), available at: http://energycommerce.house.gov/107/Hearings/06132001hearing276/hearing.htm
9.European Chamber of Commerce Taipei (ECCT) — 2002 Pharmaceutical Position Paper , available at: http://ecct.com.tw/position_papers/position_paper_pharmaceuticals_c_02.html
10.American Chamber of Commerce Taipei (AmCham), Taiwan White Paper , 2003.5 , available at: http://amcham.com.tw/dl/2003_white_paper_industry.pdf
11.International Federation of Pharmaceutical Manufacturers Association (IFPMA), (2000), Encouragement of New Clinical Drug Development: The Role of Data Exclusivity, available at: http://www.ifpma.org/documents/NR83/DataExclusivity.pdf
12.UNCTAD/ICTSD Capacity Building Project on IPR and Sustainable Development (Dec. 2002), TRIPS and Development: Resource Book- Part Two : Substantive Obligations -2.7 Protection of Undisclosed Information.
13.Carlos M. Correa, (2002), Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement, South Centre, Geneva, available at: http://www.southcentre.org/publications/protection/toc.htm
14.European Union (EU), Questions on TRIPS and Data Exclusivity. An EU Contribution, (2001), available at: http://europa.eu.int/comm/yrade/pdf/med_lic.pdf
15.The relationship between the provisions of the TRIPS Agreement and access to medicines, Communication from the European Communities and their member states , IP/C/W/280, 12 June 2001, available at: http://www.wto.org/english/tratop_e/trips_e/paper_eu_w280_e.htm16.USTR, (May 1, 2003), 2003 Special 301 Report on Intellectual Property, available at: http://www.ustr.gov/reports/2003/fullreport.pdf
17.Jonathan de Ridder, (June 2003 ), Data Exclusivity: Further Protection for Pharmaceuticals, available at : http://www.findlaw.com.au/articles/default.asp?task=read&id=9200&site=LE
18.Frederick M. Abbott, (September 2001), The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference, Quaker UN Office-Geneva, available at: http://www.geneva.quno.info/main/search_publication.php?loop=0#WHO
19.WHO, (2000), The TRIPS Agreement and Pharmaceuticals - Report of an ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals, Jakarta, 2-4 May 2000,available at: http://www.who.int/medicines/library/dap/aseantripsagreement.pdf
20.David Reiffen and Michale R. Ward, (February, 2002) Generic Drug Industry Dynamics.”, available at: http://www.ftc.gov/be/workpapers/industrydynamicsreiffenwp.pdf
21.Joseph Straus, WIPO-UPOV Symposium on the Co-Existence of Patents and Plant Breeders’ Rights in the Promotion of Biotechnological Developments (2002.10.25): Measures Necessary for the Balanced Co-existence of Patents and Plant Breeders’ Rights — A Predominantly European View, available at: http://www.upov.int/en/publications/gazette/pdf/wipo-upov_sym_02_inf_1_prov2.pdf
22.Peter Meier-Beck, Clinical Trials and The Patent Law’s Test Privilege, available at: http://www.italy.les-europe.org/docs/meier.pdf
23.Michael Fysh, LES-Italy Conference on Legal Issues in Exploriting Drug Patents in Europe (2002.12.12-13)：Infringement, Experimental use and Clinical trials: The experience of the United Kingdom and Ireland, available at: http://www.italy.les-europe.org/docs/fysh.doc
24.Canada-Patent Protection of Pharmaceutical Products-Complaint by the European Communities and their Member States, Report of the Panel, WTO document, WT/DS114/R (Mar. 17, 2000), available at: http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf
25.PhRMA,(2004), PhRMA''s 2004 Submission to the U.S. Trade Representative for the Special 301 Report” available at: http://www.phrma.org/international/resources/2004-02-12.582.pdf
26.Anita Nador and Melanie Szweras, (March 2002), Comparing Canadian Notice of Compliance (NOC) Regulations for Patented Medicines with Corresponding United States and European Union Provisions, Bereskin & Parr, available at: http://www.bereskinparr.com/publications/pdf/Bio-NOC-Regul-Nador.pdf
27.IFPMA, (2004), Encouragement of New Clinical Drug Development: The Role of Data Exclusivity, available at: http://www.ifpma.org/documents/NR356/DE_01_16_2004_2.doc
28.PhRMA, 2004 Pharmaceutical Industry Profile-Focus on Innovation, available at: http://www.phrma.org/publications/publications//2004-03-31.937.pdf
29.IMS HEALTH, Data exclusivity- the generics market’s hurdle, available at: http://www.ims-global.com//insight/news_story/0201/news_story_020109.htm
英文期刊
1.DiMasi, R. W. Hansen, H. G. Grabowski, (2003), The Price of Innovation: New Estimates of Drug Development Costs, 22 Journal of Health Economics 151
2.Phillip B.C. Jones, (2002), Navigating the Hatch-Waxman Act’s Safe Harbor, 57 Food & Drug L. J. 475
3.H.G. Grabowski, J. Vernon, and J.A. DiMasi, (2002), Returns on Research and Development for 1990s New Drug Introductions, 20 Pharmacoeconomics, suppl. 3
4.John F. Niblack, (1997), Why are Drug Development Programs Growing in Size and Cost? A View From the Industry, 52 Food & Drug L. J. 151
5.Ronald L. Desrosiers, (Fall, 1989), The Drug Patent Term: Longtime Battleground in the Control of Health Care, 24 New Eng. L. Rev. 115
6.Fortune 500: How the Industries Stack up, FORTUNE, April 15, 2002
7.Alfred B. Engelberg, (1999), Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, 39 J. L. & Tech. 396
8.Gerald J. Mossinghoff, (1999), Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process, 54 Food & Drug L. J. 187
9.Ralph A. Lewis, Comment, (1992), The Emerging Effects of the Drug Price Competition and Patent Term Restoration Act of 1984, 8 J. Contemp. Health L. & Pol’y 361
10.Holly Soehnge, (2003), The Drug Price Competition and Patent Term Restoration Act of 1984: Fine-Tuning the Balance Between the Interests of Pioneer and Generic Drug, 58 Food & Drug L. J. 51
11.Janet A. Gongola, (2003), Prescriptions for Change: The Hatch-Waxman Act and New Legislation to Increase the Availability of Generic Drugs to Consumers, 36 Ind. L. Rev. 787
12.Ollila, E. and Hamminki, E., (1996), Secrecy in drug regulation, 9 International Journal of Risk & Safety in Medicine 169
13.M.N. Graham Dukes, (1996), Drug regulation and the tradition of secrecy, International Journal of Risk & Safety in Medicine, No.9
14.G. Lee Skillington and Eric M. Solovy, (Fall, 2003), The Protection of Test and Other Data Required by Article 39.3 of the TRIPS Agreement, 24 NW. J. Int’l L. & Bus. 1
15.C. M. Correa, (2002), Public health and International Law: Unfair Competition Under the Trips Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals, 3 Chi. J. Int’l L. 69
16.R. F. Kingham, G. H. Castle, (2000), Data and Marketing Exclusivity for Pharmaceuticals in the European Community, 55 Food & Drug L. J. 209.
17.Carlos Ｍ. Correa, (2000), Implementing National Public Health Policies in the Framework of the WTO Agreements, 34 J. World Trade 89
18.Greg Perry, (2002), Data Exclusivity- A Major Threat to Access to Affordable Medicines, Business Briefing : Pharmagenerics 16
19.Thomas Cottier, (1991), The Prospects for Intellectual Property in GATT, 28 Common Market L. Rev. 383
20.Jorg Reinbothe and A. Howard, (1991), The State of Play in the Negotiations on TRIPS (GATT/Uruguay Round), 5 E.I.PR. 157
21.Gregory N. Pate, (Spring 2002), Analysis of the Experimental Use Exception, 3 N.C. J. L. & Tech. 253
22.Keiji Kondo, Clinical Testing Falls into Permissible R&D Exception of Patent Infringement, 26 AIPPI Journal 290
23.John A. Tessensohn, (Winter, 1998), Reversal of Fortune-Pharmaceutical Experimental Use and Patent Infringement in Japan, 4 J. Int’l Legal Stud. 1
24.David L. Parker, (1994), Patent Infringement Exemptions for Life Science Research, 16 Hous. J. Int’l L. 615
25.Christopher Health, (Nov. 1997), The Patent Exception for “Experimental Use” in Clinical Trials: Germany, Japan, and the U.S. Compared, 22 AIPPI Journal 267
26.Jennifer A. Johnson , (Mar. 2003), The Experimental Use Exception in Japan: A model for U.S. Patent Law?, 12 Pac. Rim L. & Pol’y J. 499
27.Lorna Brazell, (2002), The Protection of Pharmaceutical Products and Regulatory Data: E.U. Enlargement Update, 24 (3) E.I.P.R. 155
28.Richard Binns & Bryan Driscoll, (May 1999), Are the generic companies winning the battle? 89 Managing Intell. Prop. 36
29.Natalie M. Derzko, (2003), A Local and Comparative Analysis of the Experimental Use Exception─Is Harmonization Appropriate? 44 J. L. & Tech. 1.
30.Edward Hore, (2000), A comparison of United States and Canadian Laws as They Affect Generic Pharmaceutical Market Entry, 55 Food & Drug L. J. 373
判決
1.Roche Products v. Bolar Pharm. Co., 733 F.2d 858 (Fed. Cir. 1984)
2.Watson Pharm., Inc. v. Henney, No.S 00-3516, 2001 U.S. Dist. LEXIS 2477 (D. Md. Jan 18, 2001)
3.TorPharm, Inc. v. Shalala, No. 97-1925, 1997 U.S. Dist. LEXIS 21983 (D.D.C. Sep. 15, 1997)
4.Mylan Pharmaceuticals, Inc. v. Shalala, 81 F. Supp. 2d 30 (D.D.C. 2000)
5.Andrex Pharm., Inc. v. Biovail Corp., No. 02-1025, 2002 U.S. App. LEXIS 725 (Fed. Cir. Jan 17, 2002)
6.In re:Buspirone Patent Litigation, 2002 U.S. Dist. LEXIS 2626 (S.D.N.Y. Feb. 20, 2002)
7.In re:Buspirone Antitrust Litigation, No. 1410, 2002 U.S. Dist. LEXIS 2626 (S.D.N.Y. Feb. 20, 2002)
8.Pharmachemie B.V. v. Barr Labs, Inc., 2002 U.S. App. LEXIS 778
9.C-368/96, The Queen v. The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd., The Wellcome Found. Ltd. and Glaxo Operations UK Ltd. And Others, 1998 E.C.R. I-7976.
10.Bayer Inc. v. Attorney General of Canada et al., 84 C.P.R. (3d) 129, (Fed. Ct., Trial Div. 1998)
11.Bayer Inc. v. Attorney General of Canada, Apotex Inc. et al., Intervenors, 87 C.P.R. (3d) 293 (Fed. Ct. of Appeal 1999)
12.Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D Mass. 1813)
13.Sawin v. Guild, 21 F. Cas. 554 (C.C.D. Mass. 1883)
14.Jones v. Pearce, Webster’s Patent Case 122 (K.B. 1832).
15.Infigen, Inc. v. Advanced Cell Technologies, Inc., 65 F. Supp. 2d 967 (W.D. Wis. 1999).
16.Imperial Chemical Industry v. Henkel Corporation, 545 F. Supp. 635 (1982)
17.Cimotti Unharing Co. v. Derboklow, 87 F. 997 (C.C.E. D.N.Y. 1898)
18.Northill Co. v. Danforth, 51 F. Supp. 928 (N.D. Cal. 1942).
19.Akro Agate Co. v. Master Marble Co., 18 F. Supp. 305 (N.D.W.V. 1937)
20.Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp. 1269 (N.D. Cal. 1991)
21.Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3F. Supp. 2d 108 (D. Mass. 1998)
22.NeoRX Corp. v. Immunomedics, Inc, 877 F. Supp. 202 (D.N.J. 1994)
23.Biogen, Inc. v. Schering AG, 954 F. Supp. 391 (D. Mass. 1996)
24.Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990)
25.Abtox, Inc. v. Extrion Corp. and MDT Corp., 122 F.3d 1019 (Fed. Cir. 1997)
26.Bristol-Myers Squibb Co. v. Rhone-Poulene Rorer, Inc., 2001 U.S. Dist. LEXIS 19361, at 9 (S.D.N.Y. Nov. 27, 2001)
27.Klinische Versuche Clinical Trials I, 1997 R.P.C 623 (Fed. Sup. Ct. of Germany 1995)
28.Klinische Versuche Clinical Trials II, 1998 R.P.C 423 (Fed. Sup. Ct. of Germany 1998)
29.Monsanto Co. v. Stauffer Chem. Co. & Another, [1985] RPC 515 (Court of App. — Civ. Div. 1985)
30.Auchinloss v. Agric. & Veterinary Supplies Ltd., [1999] RPC 397(Court of App. — Civ. Div. 1998)
31.Science Union v. Biophelia, TGI Paris, 3rd Chamber, 2nd Section, January 25, 2002, PIBD No. 747, III
32.日本最高裁判所平成10年第153號判決